Previsto sí estaría lo único que me parece que no lo habían nombrado específicamente. Es un tema de tamaño e importancia. No es un evento demasiado relevante de cara al precio.
EMA ha dicho que están al final de la evaluación de NVAX y listos para decidir sobre su aprobación de emergencia tan pronto como puedan.
Ojalá puedan empezar a enviar ya y las plantas de Europa tengan producto. Sería muy importante aprobación y envíos en diciembre.
A pesar de la escabechina en el sector, como el bicho sigue siendo subestimado por casi todos, por encima de $200. Recuerdo que el 1 de diciembre es el evento de vacunas de Sanofi. Tengo la sensación de que la vacuna de Sanofi es mucho menos competencia que lo que el mercado cree (por varias razones), pero voy a actuar como si fuera la mayor amenaza al precio en estos momentos (porque podría serlo).
Marco Cavaleri, head of Head of Biological Health Threats and Vaccines Strategy at EMA mentioned Novavax at the end of briefing. When asked about rolling reviews of 3 new vaccines, he made a clear distinction between Novavax vs sinovac and Sputnik.
***** For novavax, they are at FINAL stages of review and ready to approve as soon as possible. But for Sinovac and Sputnik, he said because they are doing tight regulations approvals are taking time but those two will eventually get approved. Link in reply. Skip to 49:00. *****
#20553
Re: Novavax (NVAX): Un Nuevo Comienzo
aun puede subir la acción?
#20554
Re: Novavax (NVAX): Un Nuevo Comienzo
Investing esto es lo que he recibido del TGA, creo que idéntico a lo que pusiste tú en su momento:
Dear Javier
Thank you for your emails ( si, os he mandado 4 xD) concerning the Novavax COVID-19 vaccine.
On 29 October 2021 the TGA received the submission for the Novavax COVID-19 vaccine, however Novavax subsequently withdrew elements of that submission and replaced it with new parts of the submission relating to product quality on 8 November. Our team immediately reviewed the new data and on 10 November 2021 responded to Novavax as we had a number of significant and specific questions around the data. We await their response.
We are in very regular contact with Novavax but the timeframes for responding to TGA’s questions are now in their hands and not ours. The timeframes of any final approval very much depend on how quickly and how completely the applicant responds to the questions that regulators such as the TGA have on their submission. Be assured that immediately we receive the required responses from Novavax we will review the responses and if the responses are adequate progress the application with the utmost urgency.The TGA can only make a regulatory decision once the complete information on the safety, efficacy (how well it works) and manufacturing quality of the vaccine has been provided by the company. We undertake a rigorous evaluation process to ensure all COVID-19 vaccines meet stringent safety and efficacy guidelines and comply with exacting manufacturing and production standards. As part of this process sponsors are required to submit a comprehensive dossier, including clinical trial data, non-clinical toxicology studies, and chemistry, risk management and manufacturing information.
At this point, the Novavax COVID-19 vaccine has not received regulatory approval in any developed country world-wide. This means that we will not be able to use completed reviews from other comparable regulators such as the UK or Canada to facilitate the TGA’s review.A vaccine is only provisionally approved by the TGA if its benefits are considered to be much greater than any potential risks. The Pfizer (Comirnaty), AstraZeneca (Vaxzevria) and Moderna (Spikevax) vaccines that are being used in the national rollout have all been provisionally approved under this robust process.
I am aware that some people have asserted that because the Novavax is a protein subunit vaccine it is may be safer and/or more efficacious than other vaccines for COVID-19. However there is no comparative evidence available or inherent reason to support this assertion. I encourage you not to delay being vaccinated based on this supposition. The existing vaccines that have been approved in Australia and in many other countries have proven to be both extraordinarily effective in reducing COVID-19 infections and safe.
If the TGA detects a safety concern with a vaccine, rapid action will be taken to address the safety issue and promptly provide information to the public. The TGA also undertakes a careful assessment of every vaccine batch before it is released in Australia to ensure that it meets required quality specifications.
The consent form for COVID-19 vaccination is required to ensure the recipient can make an informed decision on whether to receive a COVID-19 vaccination. It is important for the health care or vaccination provider to check whether the recipient has any conditions which would mean they may be at any greater risk if receiving the vaccine.
Yours sincerely
Adjunct Prof John Skerritt FTSE FIPAA (Vic)
Deputy Secretary for Health Products Regulation
Australian Government Department of Health
PO Box 100 Woden ACT 2606 AUSTRALIA
#20555
Re: Novavax (NVAX): Un Nuevo Comienzo
Por otro lado me han compartido esto por twitter de un grupo de NVAX en telegram:
Sí, prácticamente lo mismo. Lo que comenté entonces, están casi a la cola de prioridad, por eso igual tardan un poco en contestar. EMA, MHRA, WHO, FDA van primero.
"However there is no comparative evidence available or inherent reason to support this assertion."
Esto no es completamente cierto, pero es el mensaje correcto.
#20559
Re: Novavax (NVAX): Un Nuevo Comienzo
Framus la vela Doji es una señal de indecisión, no? A ver si cerramos bien el viernes y se decanta hacia arriba… Lo que me hacen sufrir los CFD…
#20560
Re: Novavax (NVAX): Un Nuevo Comienzo
Incluso FDA? Pobres aussies, quizá la compañía no debería haberles hecho pensar en que sería inminente…
espero que os salga bien y os lleveis un pastón, al menos el suficiente para un tratamiento contra las canas porque algunos os vais a quedar blancos entre lo que se mueve la bicha y los riesgos que tomais ... >_<
